Safety of the ______________ and future generations is a major concern for human germline gene editing.
A. parents
B. child
C. family members
D. attending physicians
Researchersaretestingseveralapproachestogenetherapy,including:
A. replacingamutatedgenethatcausesthediseasewithahealthycopyofthegene
B. inactivating,or"knockingout,"amutatedgenethatisfunctioningimproperly
C. introducinganewgeneintothebodytohelpfightadisease
D. usingantibodies
How does US FDA regulate gene therapy products?
A. Comprehensive federal laws, regulations, & guidelines help protect people who participate in clinical trials. The US FDA regulates all gene therapy products in the United States & oversees research in this area.
B. FDA's regulation includes scientific review, regulatory research, testing, & compliance activities (inspection & education). Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA.
C. The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. As with other kinds of drugs, FDA regulates the quality & safety of gene therapy products and supervises how these products are used clinically.
D. Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects, such as clinical trials, must be reviewed & approved by the FDA and an Institutional Review Board.
How does US NIH regulate gene therapy study?
A. NIH provides guidelines for investigators & institutions (such as universities & hospitals) to follow when conducting clinical trials with gene therapy.
B. These guidelines state that clinical trials at institutions receiving NIH funding for this type of research must be registered with the NIH Office of Biotechnology Activities.
C. The protocol, or plan, for each clinical trial is then reviewed by the NIH Recombinant DNA Advisory Committee (RAC) to determine whether it raises medical, ethical, or safety issues that warrant further discussion at one of the RAC's public meetings.
D. NIH does not regulate gene therapy trials that are not funded by NIH.
Whichofthefollowingstatementson"NIHGuidelinesforResearchInvolvingRecombinantorSyntheticNucleicAcidMolecules(2016)"arecorrect?
A. Theguidelinesdetailsafetypracticesandcontainmentproceduresforbasicandclinicalresearchinvolvingrecombinantorsyntheticnucleicacidmolecules,includingthecreationanduseoforganismsandvirusescontainingrecombinantorsyntheticnucleicacidmolecules.
B. ThepurposeoftheNIHGuidelinesistospecifythepracticesforconstructingandhandling:(i)recombinantnucleicacidmolecules,(ii)syntheticnucleicacidmolecules,includingthosethatarechemicallyorotherwisemodifiedbutcanbasepairwithnaturallyoccurringnucleicacidmolecules,and(iii)cells,organisms,andvirusescontainingsuchmolecules.
C. InthecontextoftheNIHGuidelines,recombinantandsyntheticnucleicacidsaredefinedas:(i)moleculesthata)areconstructedbyjoiningnucleicacidmoleculesandb)thatcanreplicateinalivingcell,i.e.,recombinantnucleicacids;(ii)nucleicacidmoleculesthatarechemicallyorbyothermeanssynthesizedoramplified,includingthosethatarechemicallyorotherwisemodifiedbutcanbasepairwithnaturallyoccurringnucleicacidmolecules,i.e.,syntheticnucleicacids,or(iii)moleculesthatresultfromthereplicationofthosedescribedin(i)or(ii)above.
D. ForaclinicaltrialsitethatisaddedafterthecompletionoftheNIHprotocolregistrationprocess,noparticipantsshouldbeenrolledattheclinicaltrialsiteuntilIBCapprovalandIRBapprovalfromthatsitehavebeenobtained.
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